FDA advisory panel rejects PFE’s tafamidis by 13-4 vote:
This is not entirely true. They voted against clinical endpoint 13-4, but voted for surrogate endpoint with exact same 13-4 vote.
From PFE PR:
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer’s clinical data package for tafamidis meglumine. Tafamidis is a novel, investigational, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment. The Advisory Committee did not find substantial evidence of efficacy on a clinical endpoint. The Committee then voted 13-4 that the data provide substantial evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. This recommendation will be taken into consideration by the FDA when making its decision on Pfizer’s New Drug Application (NDA) for tafamidis as a treatment for TTR-FAP, a rare and fatal neurodegenerative disease.
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